News

Managed Healthcare Executive3d
FDA Sets Action Date for Eylea HD in Retinal Vein Occlusion
If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.
PharmExec2d
FDA Grants Priority Review to Regeneron’s Eylea for Macular Edema Following Retinal Vein Occlusion
Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...
MPR3d
High Dose Aflibercept Gets Priority Review for Retinal Vein Occlusion and Monthly Dosing
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...
Nasdaq3d
Regeneron Announces FDA Acceptance of Priority Review for EYLEA HD® Supplemental Application for Retinal Vein Occlusion Treatment
There are two main types of RVO: central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). In CRVO, the buildup occurs in the eye’s central retinal vein and in BRVO ...
Seeking Alpha3d
EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly ...
There are two main types of RVO: central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). In CRVO, the buildup occurs in the eye’s central retinal vein and in BRVO ...
GlobalData on MSN3d
FDA to review Regeneron’s sBLA for aflibercept injection 8mg
The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...
Ophthalmology Times4d
Aflibercept: Applications for dosing duration and additional indications pending decision with FDA and EMA
Regeneron aims for FDA approval of extended dosing for EYLEA HD in AMD and DME, with a decision by April 2025. Pre-filled ...
Biocon Biologics Secures Market Entry Date for Yesafili™, an Interchangeable Biosimilar to Eylea®, in the U.S.
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today a settlement and license agreement with ...
Biocon Biologics Ltd.: Biocon Biologics Secures Market Entry Date for Yesafili, an Interchangeable Biosimilar to Eylea, in the U.S.
BRIDGEWATER, N.J. and BENGALURU, Karnataka, India, April 15, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon ...
Drug Store News4d
Biocon Biologics secures market entry date for Eylea biosimilar
Yesafili, a vascular endothelial growth factor inhibitor, is used to treat several different types of ophthalmology ...